HealthyPhase 1NCT03103451
First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects
A Phase 1 study testing BCD-121 in people with Healthy, run by Biocad.
Trial summary
This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa. The study will enroll 28 healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BCD-121
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singed informed consent
- male gender
- 18-45 years of age inclusively
- BMI between18.5-30.0 kg/sq.m.
- absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis
- parameters of complete blood count, blood biochemistry, and urinalysis do not exceed reference values, which are used at Study site laboratory
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- normal hemodynamic parameters
- absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and chronic inflammation
- absence of infections within 4 weeks before randomization
- absence of mental disorders or other conditions (incl. depression), which may affect the ability of participant to follow Protocol
- health well-being (by volunteer's opining opinion) for at least 30 days before randomization.
- absence of alcohol or drug addiction signs (incl. history of such addiction)
- volunteer's ability to follow Protocol procedures
- consent of volunteers and their sexual partners with childbearing potential to use adequate contraception
Who cannot join
- history of use of monoclonal antibodies against IL-17 or TNFa
- known severe allergy (anaphylaxis or multidrug intolerance)
- known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-121/placebo
- major surgery within 30 days prior screening
- severe infections (required hospitalization, parenteral use of antimicrobial agents)
- systemic use of antimicrobials
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- more than 4 episodes of respiratory tract infections within 6 months prior the screening
- presence of any disorders which may affect pharmacokinetics of BCD-121
- history of fever which was equal or exceeded 40 degrees in Celsius
- history of hepatic transaminases increase 2.5 x ULN
- history of seizures
- actual or prior depression, suicidal tendencies
- use of any medicines, vitamins, biologically active additives within 14 days prior the date of BCD-085 injection
- use of any medicines which affects hemodynamics or hepatic function within 30 days prior the date of BCD-121 injection
- simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation.
- previous participation in this study
About this study
Official title: A Comparative Randomized Single-Blind Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Single Escalating Subcutaneous Doses of BCD 121 in Healthy Volunteers
This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa. The study will enroll 28 healthy male volunteers.
Read the detailed description
Simultaneous blockade of IL-17 and TNFa is a potential therapeutic way of treatment of several autoimmune disorders. BCD-121 is a novel humanized monoclonal bispecific antibody against human IL17 and TNFa developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-121-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of BCD-121 when used as a single step-by-step escalating subcutaneous dose in healthy male volunteers. During this study it is expected to determine diapason of safety doses of BCD-121 (incl. MTD) which thereafter can be evaluated in phase 2 studies.
- Conditions
- Healthy
- Being tested
- BCD-121, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-121Drug
Also called monoclonal bispecific antibody against human IL-17/ TNFa
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | This cohort includes 3 subjects in BCD-121 group and 1 subject in placebo group.
Intervention: BCD-121/ placebo Receives: Drug: BCD-121; Other: Placebo |
| Cohort 2 | Experimental | This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.
Intervention: BCD-121/ placebo Receives: Drug: BCD-121; Other: Placebo |
| Cohort 3 | Experimental | This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.
Intervention: BCD-121/ placebo Receives: Drug: BCD-121; Other: Placebo |
| Cohort 4 | Experimental | This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.
Intervention: BCD-121/ placebo Receives: Drug: BCD-121; Other: Placebo |
| Cohort 5 | Experimental | This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.
Intervention: BCD-121/ placebo Receives: Drug: BCD-121; Other: Placebo |
| Cohort 6 | Experimental | This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.
Intervention: BCD-121/ placebo Receives: Drug: BCD-121; Other: Placebo |
| Cohort 7 | Experimental | This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.
Intervention: BCD-121/ placebo Receives: Drug: BCD-121; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration of BCD-121-time Curve From Zero (0) Hours to 2160 Hours After the Single Subcutaneous Injection of BCD-121
Measured: 90 days
Secondary outcomes (2)
Maximum Concentration of BCD-121 After Single Subcutaneous Injection
Measured: 90 days
Time to Maximum Concentration of BCD-121 After Single Subcutaneous Injection
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startNov 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103451
- Sponsor's protocol ID
- BCD-121-1
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Single-Blind Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Single Escalating Subcutaneous Doses of BCD 121 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03103451
- Acronym / sponsor ID
- BCD-121-1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa. The study will enroll 28 healthy male volunteers.
Detailed description
Simultaneous blockade of IL-17 and TNFa is a potential therapeutic way of treatment of several autoimmune disorders. BCD-121 is a novel humanized monoclonal bispecific antibody against human IL17 and TNFa developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-121-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of BCD-121 when used as a single step-by-step escalating subcutaneous dose in healthy male volunteers. During this study it is expected to determine diapason of safety doses of BCD-121 (incl. MTD) which thereafter can be evaluated in phase 2 studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BCD-121, Other: PlaceboThis cohort includes 3 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo |
| Cohort 2 | Experimental | Drug: BCD-121, Other: PlaceboThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo |
| Cohort 3 | Experimental | Drug: BCD-121, Other: PlaceboThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo |
| Cohort 4 | Experimental | Drug: BCD-121, Other: PlaceboThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo |
| Cohort 5 | Experimental | Drug: BCD-121, Other: PlaceboThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo |
| Cohort 6 | Experimental | Drug: BCD-121, Other: PlaceboThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo |
| Cohort 7 | Experimental | Drug: BCD-121, Other: PlaceboThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- singed informed consent
- male gender
- 18-45 years of age inclusively
- BMI between18.5-30.0 kg/sq.m.
- absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis
Key exclusion criteria (16 listed)
- history of use of monoclonal antibodies against IL-17 or TNFa
- known severe allergy (anaphylaxis or multidrug intolerance)
- known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-121/placebo
- major surgery within 30 days prior screening
- severe infections (required hospitalization, parenteral use of antimicrobial agents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-121Also: monoclonal bispecific antibody against human IL-17/ TNFa | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| Placebo | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Area Under the Plasma Concentration of BCD-121-time Curve From Zero (0) Hours to 2160 Hours After the Single Subcutaneous Injection of BCD-121
Time frame: 90 days
2 secondary outcomes
Maximum Concentration of BCD-121 After Single Subcutaneous Injection
Time frame: 90 days
Time to Maximum Concentration of BCD-121 After Single Subcutaneous Injection
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCD-121 in people with Healthy, run by Biocad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration of BCD-121-time Curve From Zero (0) Hours to 2160 Hours After the Single Subcutaneous Injection of BCD-121 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.